Package for transcutaneous injection



Jan. 8, 1963 s. R. ROSENTHAL 3,072,122

PACKAGE FOR TRANSCUTANEOUS INJECTION Filed Jan. 15, 1959 2 Sheets-Sheet1 FIG 3 l2 l2 5 15a T will "IIIIIIJ" IIIIII/ INVENTOR.

50/ Roy Rosenfha/ Jan. 8, 1963 s. R. ROSENTHAL I 3,072,122

PACKAGE FOR TRANSCUTANEOUS INJECTION Filed Jan. 15, 1959 2 Sheets-Sheet2 FIG. 10 FIG 7 FIG. 12

' INVENTOR.

/5/ [6/ 50/ Roy Rosenfhal V United. rates hatent 3,072,122 PAQKAGE F-GRTRANSCUTANEQUS HNEECTEQN Sol Roy Rosenthal, 230 Delaware Place, l1iag0,lll. Filed Ian. 15, 1959, Ser. No. 787,686 3 Qiairns. (Cl. 123253) Thepresent invention relates to a novel package for transcutaneousinjection by which inoculation or vaccination may be quickly and easilycarried out.

For many years it has been the common practice to vaccinate with variousantigens by inoculating with a syringe and an injecting needleintracutaneously, subcutaneously, or intramuscuiarly. For smallpoxvaccination the virus has commonly been introduced percutaneously bydepositing a film of the liquid vaccine on the skin and puncturing orscratching the skin through the vaccine with an ordinary needle or thelike over a relatively small area. In each of these commonly usedmethods the vaccine is concentrated in a small area and, as a resultthereof, these prior methods have often led to either generalized orlocalized reactions of a severe and undesirable character.

The present inventor some years ago discovered that such undesirablereactions could often be avoided and vaccination could be more quicklyand easily accomplished by introducing a vaccine into the skintranscutaneously by multiple punctures of identical character and depthdistributed over a substantially greater area of the skin than had beenemployed in prior vaccination methods, and on December 2, 1952,applicant was granted United States Patent No. 2,619,962 on avaccination appliance by which vaccinations could easily be madeemploying this multiple puncture technique. The vaccination appliancedisclosed in said patent comprises a thin metal plate having needlespunched therefrom and projecting in parallel relationship from one sidethereof outwardly beyond the level of the adjacent surfaces of theplate. As disclosed in the patent, vaccination was accomplished bycleaning the surface of the skin with alcohol or the like and a quantityof vaccine, in either liquid or powdered form, was then spread over thearea where the vaccination was to be effected. The vaccination appliancewas then placed against the surface to which the vaccine had beenapplied and it was pressed inwardly, thereby forming a plurality ofpunctures of the skin with a resulting transcutaneous injection of thevaccine at the site of each puncture, with out scarification of theskin.

The vaccination appliance of my prior patent is now being widely usedwith excellent results, and the present invention is related thereto incertain respects in that the present new package by which vaccinationand inoculation to skin testing may be effected more easily and quickly,utilizes a form of the appliance broadly covered by my prior patent.

One of the principal objects of the present invention is to provide aprepared package for etiecting transcutaneous inoculation, which packageis complete in itself and is of a nature such that it may be readilystored in large numbers without special precautions and may be suppliedto physicians and hospitals in the same manner as ordinary medicalsupplies. Another object of the invention is to provide a vaccination orinoculation package of the kind just stated which may be quickly andeasily used, and is ready for use immediately upon opening of thepackage. Still another object of the invention is to provide such apackage which renders unnecessary the usual use of a needle and syringefor withdrawing vaccines and skin testing materials from ampules and theusual reconstituting of such vaccines and testing materials, and rendersunnecessary the use and handling of liquid or powdered vaccines and skintesting materials by the physician or nurse, thereby greatly simplifyingvaccination procedures and eliminating or greatly reducing the chancesfor human error during the making of vaccinations and skin tests.

The new prepared package, in one of its forms, comprises a substantiallyrigid backing member having secured thereto a thin metal plate having aplurality of needle-like projections punched therefrom, and with a driedantigenic substance on each of the needle-like projections. The backingmember, in this form of the package, has removably secured thereto asubstantially rigid, imperforate, bubble-like cap that completely coversthe metal plate and its needle-like projections so as to protect theprojections and prevent contamination of the dried antigenic substancethereon prior to use of the package in inoculation. In order to make avaccination or skin testing inoculation with the package, the physicianmerely needs to clean the skin area where the vaccination or inoculationis to be made. He then opens the package by removing the cover,whereupon, by gripping the backing member in his fingers, he presses theneedle-like projections of the thin metal plate against the skin,thereby simultaneously puncturing the skin at a plurality of points. Heholds the device in this position only for a short time until the lymphor other body fluids in the deeper recesses of the skin dissolve theantigenic substance olf the embedded projections. It is desirable,although not necessarily essential, that the thin metal plate be rotatedslightly in a circular motion, but without scarification, while theneedle-like projections are embedded in the skin, thereby tending towipe all of the antigenic substance off of the projections and depositthe same in or under the skin. The vaccination or inoculation, in anyevent, will then have been completed and the instrument can be withdrawnand discarded. It will immediately be appreciated that the entirevaccination or inoculation procedure will, therefore, require only a fewmoments when one of the present new packages is employed, and that noclean-up of equipment will be needed or involved.

()ther objects and advantages of the present invention will be apparentfrom the following description of a preferred form of the package, withvariations, and a preiered manner by which it may be used. In theaccompanying drawings:

FIG. 1 shows a perspective view of the arm of a patient upon which avaccination or skin test inoculation is being made with the use of oneof my new vaccination or inoculation packages;

FIG. 2 is a side view in elevation of one of my new packages;

FIG. 3 is a top plan view thereof with the bubblelike cover removed;

FIG. 4 is an enlarged cross-sectional view taken substantially along theline 4-4 in FIG. 3, but showing the cover in place;

FIG. 5 is a similar View taken substantially along the line 5-5 in FIG.3;

FIGS. 6 and 7 are similar to FIG. 5, but they show variations in the wayin which the thin metal plate may be secured to the backing member, andthey shown a variation in the way in which the cap or cover may besecured in protective position upon the backing member;

FIG. 8 is an enlarged perspective view of one of the thin metal platesprior to mounting upon a backing member;

HG. 9 is a similar view of another form of thin metal plate which may beemployed in vaccination packages in acordance with the presentinvention;

FIG. 10 is a greatly enlarged view of one form of needle-like projectionon one of the thin metal plates, showing the projection as beingperforated in order to increase the amount of antigenic material thatmay readily be applied thereto and dried thereon pursuant to the presentinvention;

FIG. 11 is a view similar to FIG. 10, but showing a needle-likeprojection pitted or scarilied, as by sandblasting, in order to increasethe amount of antigenic material that may readily be applied thereto;and

FIG. 12 is a similar view of another needle-like projection, showing thesurface of the projection scarified as by scratching. I As illustratedin the drawings, one package embodying the present invention iscomprised of a single piece backing member 11 which has a generally flator planar central portion 12 with a pair of wing-like projections 13 and14 extending from opposite sides or ends thereof so that the backingmember may easily be held and manipulated by the fingers. The backingmember if is preferably formed of a suitable substantially rigidmoldable plastic material, such for example as polystyrene,polyethylene, nylon or Teflon. in the form of the package illustrated inFIG. 5 the central area of the central portion 12 of the backing memberis somewhat thicker than the Wing-like projections 13 and ii-d so thatthe upper side of the central portion 12. provides a raised platform12:: having a peripheral overhang 325, beneath which there is aperipheral slot 12c. This overhang 12b and the slot 120 are adapted toreceive an inwardly directed flange or lip 15a of a bubble-like cover 15which is preferably transparent and which, like the backing member 11,may be formed of a suitable molded plastic material.

In the form of the package shown in FIGS. 3 to 5, the raised platform12a has a pair of recesses 12d formed therein. The recesses 12d are ofgradually increasing depth, as best seen in FIG. 5, and the oppositeside walls of each recess are provided with projecting nibs or detents1212, beneath which there are received tongues 16a that are formedintegrally on the opposite ends of a thin metal plate 16. The undersideof the metal plate thus lies fiat against the surface of the raisedplatform 12a, with this surface, in the present case, backing-up orsupporting the backside of the plate, and particularly the area adjacentneedle-like projections or tines 16b that are formed on the plate asexplained below, and the plate is rigidly fixed and retained in thisposition by the presence of the tongues 16a in the recesses 12d and bythe detents 12a which secure the tongues in the recesses.

The plate 16, as best seen in FIG. 8, may be generally of a rectangularconfiguration with four or more sharply pointed needle-like projections16b punched from the central portion of the plate, thus leaving arectangular opening 160 at the center of the plate. The needle-likeprojections are preferably of uniform length and size and they projectat right angles from the plane of the thin metal plate 16 from 1 toabout 4 mms, depending upon the type of vaccination to be accomplished.

Each of the needle-like projections 16]; is coated with a driedantigenic substance 17, as will be more fully explained below, and thecover or cap 15 protects the projections 16b and prevents contaminationof the dried antigenic substance prior to use of the package ineffecting a vaccination or injection.

The forms of the package shown in FTGS. 6 and 7 are similar to the formshown in FIGS. 3 to 5 except as to the way in which the cover is appliedto the backing member 11 and the manner in which the metal plate 16 issecured to the backing member. In FIGS. 6 and 7 the top of the centralportion 12 of the backing member is flat and without the raised platform12a shown in FIG. 5, and the cover 15 is not provided with a lip orflange around its periphery. On the contrary, the peripheral edge 15])of the bubble-like cap or cover 15 in these modifications is plain andis removably received in a tight fit downwardly into an annular slot 12fformed in the upper surface of the central portion 12 of the backingmember. The metal plate 16 shown in FIG. 6 differs from that shown inFIGS. 3 to 5 and 8 in that the tongues 16a are apertured and the plateis secured to the central port on 12 of the backing member by means ofrivets l5 whlch extend through the apertures of the tongues and throughthe body of the central portion 12 of the backing member, the rivetspreferably having flat heads at their ends ad jacent the metal plate 16.In FIG. 7, on the other hand, the tongues on the metal plate 16 aresomewhat longer than those shown in FIGS. 3 to 6 and 8 and provide tabs-16d which extend to the rear side of the backing meme her throughapertures 12g provided in the central portion 12 thereof, where the freeends of the tabs 16a are bent over, as shown in FIG. 7, in order tosecure the rnetar plate upon the backing member. In all of the forms ofthe package described above, it will be noted that the central portion12 of the backing member, backs-up and supports the backside orunderside of the metal plate 16.

The present vaccinating packages are useful in a great variety oftranscutaneous injections and inoculations with allergens and antigensand biological substances of different kinds. Vaccines, for example,which may be injected into a patient with the use of the presentpackages include the vaccines for whooping cough, polio, rabies, yellowfever, smallpox and others including the vaccine of Calmette and Guerin,commonly called BCG, for tuberculosis. Testing materials that may beinjected by use of the present packages include (but are not limited to)coccidioidin, blasto-mycin, histoplasmin, lepromin and tuberculin, aswell as allergens for foods and pollens. In the injection of certain ofthese materials it may be desirable to use a package employing asomewhat larger metal plate with additional needle-like projectionsthereon, and an example of such a plate is shown in FIG. 9 where theplate is provided with thirty-six projections 16:) rather than the fourshown in FIG. 8. Various sizes of plates may, of course, be employedwith backing members 11 of different sizes, depending upon thevaccination rcquirements.

In preparing the packages, the metal plates 16 are cleaned and theneedle-like projections 16b thereof are thereupon coated with thedesired wet antigenic or aller-' genic or immunizing or testingsubstance by merely dip-' ping the projections into a liquid solution ofthe substance or by cataphoresic or electrophoresic deposition of thesubstance upon the projections. The amount of the wet substance retainedupon the projections may be increased by a scarification of the surfacesof the projections. This may be done in several ways. For example, inFIG. 10 the projections 16!) are shown to have been pierced by aplurality of very small openings The; in FIG. 11 the surfaces of theprojections are shown to have been roughened or pitted as bysandblasting; and in FIG. 12 the surfaces have been roughened as byscratches 16 Due to the surface tension of the antigenic or allergenicsolution, a greater amount of the wet antigenic or allergenie substanceis retained upon the projections 16b than would be the case if thesurfaces of the projections were smooth. In any event, the projections16b are then removed from the solution and the antigenic or similarsubstance is then dried upon the projections. In the case of mostnon-viable antigens this drying may be carried out in air at about 37 C.In the case of viable antigens, however, it is preferable to freeze-drythe substance upon the projections. In so doing, the wet substance isfirst frozen upon the projections by lowering the temperature to as muchas minus 45 C., whereupon the metal plates with the frozen materialthereon are placed in a vacuum chamber and left there for from 7 to 18hours while the temperature is permitted to rise gradually to about 20C.,

The thin metal plates 16, with the dried antigenic substance upon theprojections 16b thereof, are then secured in backed-up position upon thebacking members 11. In the case of the package illustrated in FIGS. 3'to 5 this. is done simply by flexing the tongues 16a downwardly intovvthe recesses 12d and snapping the tongues past the detents 12c. Thedetents 12c thereupon retain the plate 16 in place. In the case of thepackage of FIG. 6 the tongues 16a are riveted in place, as shown, and inthe case of the package of FIG. 7, the tabs 16d are pushed through theapertures 12g and are then bent over on the underside of the backingmember 11 in order to retain the plate 16 upon the backing member. Whenthe antigenic substance on the projections 16b is of a non-viable type,the assembled plates and backing members and the caps 15 are thenappropriately sterilized, such as by steam or ethylene oxide or by anyother suitable sterilizing compound. When the antigenic substance is ofa viable type, on the other hand, sterilization must be accomplishedbefore the substance is applied to the projections 16b. In the case ofthe package of FIGS. 3 to 5, the cover 15 is pressed downwardly onto thebacking member so that the annular lip or flange 15a snaps over theoverhanging shoulder 12b and comes to rest in the annular groove 12c, asbest shown in FIG. 5. The cooperation of the shoulder 125 with theflange 15a thereupon retains the cover in place and effectively sealsthe prepared plate 16 so as to protect the coated projections 16b andprevent contamination of the antigenic substance 17 thereon.

In the case of the packages shown in FIGS. 6 and 7, the cap 15 isapplied merely by pressing the cap downwardly so that its peripheraledge 15b seats in the annular groove 12 formed in the upper surface ofthe backing member 11. The tight fit between the lower edge 15b of thecap and the slot 12 effectively retains the cap in place and maintainsthe sterile condition of the thinmetal plate 16 and the coatedprojections 16b thereon.

It will readily be appreciated that the present packages may be easilyproduced in great number and, when effectively sealed as describedabove, may be stored for substantial periods at various places about thecountry and may be supplied, to physicians in normal channels of trade,as is the case with ordinary medical supplies.

When it is desired to effect a vaccination or skin test inoculation withone of the present packages, the package having the appropriate driedantigenic or biological substance on the projections 16b therein isselected. The skin of the patient is sterilized by alcohol or the likeand the cap 15 of the package is then removed. In the case of thepackage illustrated in FIGS. 3 to 5, removal of the cap is facilitatedby pressing the center of the cap with the fingers, thus tending tospread or separate the annular edges of the cap and making it easier toremove the cap from the backing member 11. In the case of the packagesof FIGS. 6 and 7, the cap 15 in each case is merely forced out of theannular groove 12 This may be facilitated by manually flexing thebacking member 11 slightly. Gnce the cap 15 has been removed from theappropriate package, the backing member 11 is held in the hand and thesharp, pointed and coated projections 16!; are pressed into the skin ofthe patient in the manner illustrated in FIG. 1, the wings 13 and 14being pressed by the operators thumb and second finger and with theindex finger bearing upon the central portion 12 of the backing member11, so that the projections 16b penetrate the skin and carry the driedantigenic or biological substance thereinto. It will be appreciated thatdurin this penetration of the projections 16b into the skin, the backingmember 11 backs-up or supports and tends to rigidify the thin metalplate 16 so that, despite its thin gauge, there is little or no bendingof the plate, with the result that all of the projections 16b maypenetrate to a substantially uniform depth predetermined by the lengthof the projections. This uniformity of depth of penetration is importantin many different kinds of injections such, for example, as inperforming skin tests wherein each penetration site is in fact a testsite, and different depths of penetration may tend to result indifferent or undesired test reactions at the different sites.

When the projections 16b have penetrated to the desired depth thebacking member 11 is then held in this position for a few moments by theoperator until the lymph and other body fluids in the deeper recesses ofthe skin dissolve the dried antigenic or biological substances from thepoints of the projections 16b. With the backing member held as justdescribed, the backing member is gripped between the thumb and secondfinger and is preferably given a gentle rotary motion while theprojections 16b are still embedded in the skin. This tends to insurethat all of the antigenic or biological substance is removed from theprojections and deposited in or beneath the skin. The vaccination willthen have been completed, and the holder 11, with the metal plate 16still intact thereon, may then be removed from the patients skin anddiscarded.

The foregoing description of the present vaccination package withcertain variations thereof, and the description of the method by whichthe packages are prepared and employed in effecting vaccinations orinoculations, have been given for clearness of understanding only and nounnecessary limitations are intended thereby, for it will be apparent tothose skilled in the art that various modifications may be made in thepackages and in the method of their preparation and use, withoutdeparting from the spirit and scope of the claims appended hereto.

I claim:

1. A prepared package for use in transcutaneous injection, comprising asubstantially rigid backing member adapted to be conveniently gripped inand manipulated by the fingers, said backing member having thereon aplate-receiving back-up surface, a thin plate having a plurality ofneedle-like skin perforating projections extending from one facethereof, means fixedly securing said plate upon said backing member withthe opposite face of said thin plate lying against and in intimatecontact with said back-up surface, a dried, biological substance on saidneedle-like projections, said needle-like projections being adaptedsimultaneously to puncture and penetrate the skin at a plurality ofpoints and to introduce said biological substance into the body whensaid backing member and said plate are pressed by the fingers againstthe skin, said back-up surface serving to support and reinforce saidplate during the penetration of said needle-like projections into theskin and thereby avoid any tendency of said plate to flex undesirablyduring such penetration, and a substantially, rigid, imperforateprotective cover removably secured to said backing member and coveringsaid plate and said needle-like projections for protecting saidneedle-like projections and preventing contamination of said biologicalsusbtance prior to use of the package in injection.

2. A prepared package for use in transcutaneous injection, comprising asubstantially rigid backing member adapted to be conveniently gripped inand manipulated by the fingers, said backing member having thereon aplatereceiving back-up surface, a thin metal plate having a plurality ofneedle-like projections punched therefrom and extending from one facethereof, means fixedly securing said plate upon said backing member withthe opposite face of said plate, in the areas thereof adjacent saidneedlelike projections, lying against and in intimate contact with saidback-up surface and with said needle-like projections extendingoutwardly beyond the level of all adjacent surfaces of said plate andsaid backing member, a dried biological substance on said needle-likeprojections, said needle-like projections being adapted simultaneouslyto puncture and penetrate the skin at a plurality of points and tointroduce said biological substance into the body when said backingmember and said plate are pressed by the fingers against the skin, and asubstantially rigid, imperforate protective cover removably secured tosaid backing member and covering said plate and said needle-likeprojections for protecting said needle-like projections and preventingcontamination of said biological substance prior to use of the packagein injection.

3. A prepared package for use in transcutaneous injection, comprising asubstantially rigid single-piece backing member of moidable plasticmaterial having a size and shape for convenient gripping andmanipulation by the fingers, said backing member having thereon asubstantially flat plate-receiving back-up surface, a thin metal platehaving a substantially fiat portion thereon, a plurality of needle-likeprojections punched from said flat portion of said plate and extendingfrom one face thereof, means rigidly securing said plate upon saidbacking member with the other face of said fiat portion of said platelying against and in intimate contact with said back-up surface, a driedbiological substance on said needle-like projections, said needle-likeprojections being adapted simultaneously to puncture and penetrate theskin at a plurality of points and to introduce said biological substanceinto the body when said backing member and said plate are pressed by thefingers against the skin, said flat back-up surface serving to supportand reinforce said fiat portion of said plate during the penetration ofsaid needle-like projections into the skin and thereby avoid anytendency of said fiat portion of said plate to flex undesirably duringsuch penetration, and a substantially rigid, imperforate protectivecover removably secured to said backing member and covering said plateand said needle-like projections for protecting said needle-likeprojections and preventing contamination of said biological substanceprior to use of the package in injection.

4. The combination set forth in claim 3, wherein said substantiallyrigid single-piece backing member includes a pair of substantiallyrigid, integral, laterally extending,

wing-like projections by which said backing member may conveniently beheld by the fingers.

5. The combination set forth in claim 2, wherein the surfaces of saidneedle-like projections are scarified so as to increase the amount ofbiological substance that may be received thereon.

6. The combination set forth in claim 3, wherein said plate receivingback-up surface is provided with a pair of recesses and said securingmeans includes a pair of tongues on said metal plate respectivelysecured within said recesses.

7. The combination set forth in claim 3, wherein said backing member isprovided with a pair of apertures and said securing means includes apair of tabs formed on said metal plate and respectively extendingtirough said apertures, the free ends of said tabs being bent over toprevent withdrawal of said tabs fron said apertures.

8. The combination set forth in claim 3, wherein said thin metal plateis riveted upon said plate-receiving back- .up surface.

References Cited in the file of this patent UNITED STATES PATENTS OTHERREFERENCES Cross Article, The Lancet, Mar. 2, 1957, pp. 446448.

1. A PREPARED PACKAGE FOR USE IN TRANSCUTANEOUS INJECTION, COMPRISING ASUBSTANTIALLY RIGID BACKING MEMBER ADAPTED TO BE CONVENIENTLY GRIPPED INAND MANIPULATED BY THE FINGERS, SAID BACKING MEMBER HAVING THEREON APLATE-RECEIVING BACK-UP SURFACE, A THIN PLATE HAVING A PLURALITY OFNEEDLE-LIKE SKIN PERFORATING PROJECTIONS EXTENDING FROM ONE FACETHEREOF, MEANS FIXEDLY SECURING SAID PLATE UPON SAID BACKING MEMBER WITHTHE OPPOSITE FACE OF SAID THIN PLATE LYING AGAINST AND IN INTIMATECONTACT WITH SAID BACK-UP SURFACE, A DRIED, BIOLOGICAL SUBSTANCE ON SAIDNEEDLE-LIKE PROJECTIONS, SAID NEEDLE-LIKE PROJECTIONS BEING ADAPTEDSIMULTANEOUSLY TO PUNCTURE AND PENETRATE THE SKIN AT A PLURALITY OFPOINTS AND TO INTRODUCE SAID BIOLOGICAL SUBSTANCE INTO THE BODY WHENSAID BACKING MEMBER AND SAID PLATE ARE PRESSED BY THE FINGERS AGAINSTTHE SKIN, SAID BACK-UP SURFACE SERVING TO SUPPORT AND REINFORCE SAIDPLATE DURING THE PENETRATION OF SAID NEEDLE-LIKE PROJECTIONS INTO THESKIN AND THEREBY AVOID ANY TENDENCY OF SAID PLATE OF FLEX UNDESIRABLYDURING SUCH PENETRATION, AND A SUBSTANTIALLY, RIGID, IMPERFORATEPROTECTIVE COVER REMOVABLY SECURED TO SAID BACKING MEMBER AND COVERINGSAID PLATE AND SAID NEEDLE-LIKE PROJECTIONS FOR PROTECTING SAIDNEEDLE-LIKE PROJECTIONS AND PREVENTING CONTAMINATION OF SAID BIOLOGICALSUBSTANCE PRIOR TO USE OF THE PACKAGE IN INJECTION.